What happened
Shares of Novavax (NVAX 5.30%) were jumping 3.1% as of 10:01 a.m. ET on Wednesday after rising as much as 11.3% earlier in the day. The move came after a U.S. Food and Drug Administration (FDA) advisory committee voted 21-0 with one abstention on Tuesday in favor of recommending Emergency Use Authorization (EUA) for Novavax's COVID-19 vaccine NVX-CoV2373.
So what
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) concluded that the benefits of NVX-CoV2373 outweighed any potential risks. One of those risks was highlighted in the FDA's briefing documents released last week. The data for NVX-CoV2373 revealed multiple adverse events of myocarditis (inflammation of the heart).
Some investors were worried about the possible impact on Novavax's prospects with the advisory committee's deliberations. The vaccine stock plunged close to 20% at one point last week.
However, the FDA's briefing documents stated that there wasn't enough data to conclude that Novavax's vaccine caused the cases of myocarditis. The VRBPAC didn't appear to be overly concerned in light of the very low number of adverse events and the solid efficacy for NVX-CoV2373.
Image source: Getty Images.
Importantly, Novavax noted in its announcement of the advisory committee's decision that the overall rate of myocarditis was similar between the groups of patients receiving NVX-CoV2373 and a placebo. The company also stated that "in the post-crossover portions of Novavax trials the observed cases were all within the expected rate."
Now what
The FDA must now make its official decision on EUA for NVX-CoV2373 in adults ages 18 and older. Although the agency doesn't have to go along with the advisory committee's recommendation, it seems likely to do so.
